De Novo DEN220066

Device
BrainSee
Contact
kaveh vejdani
De Novo number
DEN220066
Product code
QWT
Regulation
882.1454
Classification name
prognostic assessment software of mild cognitive impairment
Decision
granted (DENG)
Decision date
2024-01-11
Date received
2022-09-29
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct

Current FDA Classification#

Product code
QWT
Device name
Prognostic Assessment Software Of Mild Cognitive Impairment
Medical specialty
Neurology
Device class
2
Regulation
882.1454
Implant
N
Life sustain/support
N